Drug intelligence / Profile preview

amitriptyline + estriol

Development stage
Unknown
Lead developer
Zenith Technology Corp
Modality
Small Molecules
Administration
Topical
01

Overview

Mi-Gel is a proprietary topical organogel formulation containing a combination of amitriptyline (0.5%) and estriol (0.03%). Developed by Zenith Technology Corporation Limited, it is indicated for the treatment of localized vulvo-vaginal pain conditions, including vulvodynia, pudendal neuralgia, vestibulitis, and dyspareunia. The amitriptyline component acts as a membrane stabilizer by blocking neuronal sodium channels, which reduces mucosal sensitivity and alleviates chronic pain. The estriol component, a weak estrogen, promotes mucosal regeneration, improves tissue flexibility, and enhances lubrication. The drug is currently being evaluated in pivotal bioequivalence trials to support its clinical use as a localized therapy with minimal systemic exposure.

Brand names
Mi-Gel
Other names
amitriptyline 0.5% / estriol 0.03% topical gel
02

Targets

GPER1 (G protein-coupled estrogen receptor 1)ADRA1A (α1A)HRH1 (Histamine H1 Receptor)mAChR (Muscarinic acetylcholine receptors)SERT (Sodium-dependent serotonin transporter)KCNH2 (Voltage-gated potassium channel subfamily H member 2)NET (Norepinephrine Transporter)ESR1 (ERα)NaV (Voltage-gated sodium channels)ESR2 (ERβ)

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